FDA.reportPublic FDA data

ASTEC

Primary DI
B951AI5030V1
Brand
ASTEC
Company
ASTEC BIO USA INC
Model
ICSI Injection Pipette
Catalog number
AI5030-V
Device description
7µm OD, 5.0µm ID, 30° Tip Bevel, 30° Neck Angle, 0.55mm Tip to Elbow, Spiked
Published
2020-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUCMicrotools, Assisted Reproduction (Pipettes), Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUCMicrotools, Assisted Reproduction (Pipettes), ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B951AI5030V1PrimaryHIBCC0
B951AI5030V0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction microtoolA dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature16 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
041434170
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B951AI4530TL0AstecInjection PipetteAI4530-TL2025-01-29
B951AH12030L1ASTECHolding PipetteAH12030-L2022-12-17
B951AB3030X1ASTECBlastomere Biopsy PipetteAB3030-X2020-11-12
B951AB3030Z1ASTECBlastomere Biopsy PipetteAB3030-Z2020-11-12
B951AB3530X1ASTECBlastomere Biopsy PipetteAB3530-X2020-11-12
B951AB3530Z1ASTECBlastomere Biopsy PipetteAB3530-Z2020-11-12
B951AB4030X1ASTECBlastomere Biopsy PipetteAB4030-X2020-11-12
B951AH100201ASTECHolding PipetteAH100202020-11-12
B951AH100351ASTECHolding PipetteAH100352020-11-12
B951AH120201ASTECHolding PipetteAH120202020-11-12
B951AH12020B1ASTECHolding PipetteAH12020-B2020-11-12
B951AH120351ASTECHolding PipetteAH120352020-11-12
B951AH12035B1ASTECHolding PipetteAH12035-B2020-11-12
B951AH7030S1ASTECHolding PipetteAH7030-S2020-11-12
B951AH9030L1ASTECHolding PipetteAH9030-L2020-11-12
B951AI4020YL1ASTECICSI Injection PipetteAI4020-YL2020-11-12
B951AI4025YL1ASTECICSI Injection PipetteAI4025-YL2020-11-12
B951AI4030HL1ASTECICSI Injection PipetteAI4030-HL2020-11-12
B951AI4030V1ASTECICSI Injection PipetteAI4030-V2020-11-12
B951AI4030YQ1ASTECICSI Injection PipetteAI4030-YQ2020-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816633020776SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020783SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020790SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020806SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020813SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020820SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020837SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020844SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020851SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020868SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020875SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020899SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020905SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020912SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020929SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020936SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020943SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020950SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020967SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020974SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020981SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020998SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021957SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021964SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021971SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021988SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021995SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022497SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022503SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022510SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27